FENTANYL CITRATE lozenge

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FENTANYL CITRATE (UNII: MUN5LYG46H) (FENTANYL - UNII:UF599785JZ)

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

FENTANYL CITRATE

Composition:

FENTANYL 800 ug

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FENTANYL CITRATE- FENTANYL CITRATE LOZENGE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ORAL
TRANSMUCOSAL FENTANYL CITRATE
(OTFC) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
OTFC.
ORAL TRANSMUCOSAL FENTANYL CITRATE (OTFC), CII
INITIAL U.S. APPROVAL: 1968
WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE
POTENTIAL
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
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RECENT MAJOR CHANGES
Indications and Usage ( 1) 12/2011
Warnings and Precautions – TIRF REMS Access Program ( 5.10) 12/2011
INDICATIONS AND USAGE
Oral Transmucosal Fentanyl Citrate (OTFC) is an opioid agonist
indicated for the management of breakthrough pain in
cancer patients 16 years of age and older who are already receiving
and who are tolerant to around-the-clock opioid
therapy for their underlying persistent cancer pain ( 1).
Limitations of Use:
OTFC may be dispensed only to patients enrolled in the TIRF REMS
Access program. ( 1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Due to the risk of fatal respiratory depression, OTFC is
contraindicated in opioid non-tolerant patients (1) and in
management of acute or postoperative pain, including
headache/migraines. (4)
Keep out of reach of children. (5.3)
Use with CYP 3A4 inhibitors may cause fatal respiratory depression.
(7)
When prescribing, do not convert patients on a mcg per mcg basis from
any other oral transmucosal fentanyl
product to OTFC. (2.1, 5.1)
When dispensing, do not substitute with any other fentanyl products.
(5.1)
Contains fentanyl, a Schedule II controlled substance with abuse
liability similar to other opioid analgesics. (9.1)
Oral Transmucosal Fentanyl Citrate (OTFC) is available only through a
restricted program called the TIRF
REMS Access program. Outpatients, healthcare professionals who
prescribe to